Lyophilization Process Development (Quality By Design approach)

Product Description

With the aim of obtaining a product that meets the critical quality attributes, but with the most optimized freeze-drying process.

Our focus is the total control of the process. We develop freeze-drying processes in a previously defined design space: Quality By Design approach.

Comser

ES
2022

On CPHI since
1

Certificates
25 - 49

Employees

Company types

Biopharmaceutical company

CMO/CDMO

Contract Research Organisation (CRO)

Contract Service

Other

Pharmaceutical company

Primary activities

Biopharmaceutical

Contract Manufacturer

Contract Research Organisation

Laboratory Services

Laboratory, Analytical, Biotechnology Equipment

Other

Technology

Compare Add to favorites Added to favorites

Specifications

Supplied from

Spain

Comser

ES
2022

On CPHI since
1

Certificates
25 - 49

Employees

Company types

Biopharmaceutical company

CMO/CDMO

Contract Research Organisation (CRO)

Contract Service

Other

Pharmaceutical company

Primary activities

Biopharmaceutical

Contract Manufacturer

Contract Research Organisation

Laboratory Services

Laboratory, Analytical, Biotechnology Equipment

Other

Technology

Compare Add to favorites Added to favorites

Frequently Viewed Together

Product OTC and MD dossiers

A list of regulatory OTC dossiers compliant with European regulations and in CTD structure (NEES-eCTD) is available. These dossiers are ready to be audited by clients and to be submitted for registration to Health Authorities. We provide support during the registration process until the dossiers are author...
Product Dissolution Testing - R&D services

For us dissolution testing is never a routine test but an essential tool in pharmaceutical formulation development to:

• evaluate the physicochemical properties of drug candidates to select the most appropriate solid form for further development (pre-formulation)
• compare pro...
Product Formulation Development

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.
Product IND Enabling Preformulation Package (IEPP)

WuXi STA's IND Enabling Pre-formulation Package (IEPP) is an integrated and end-to-end developability assessment service for new chemical entities (NCE's). Through this comprehensive service, you can efficiently identify challenges and tailored solutions earlier for higher project success rates and lower o...
Product Biologic drug substance CDMO services

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
Product Inhaled Drug Development

Quotient has a 30 year track record in the development and manufacturing of inhaled drug products. We have experience across a range of drug delivery platforms including dry powder inhalers (DPIs) and solutions/suspensions for inhalation. With integrated capabilities and vast knowledge of nasal and pu...
Product Manufacturing Solutions

We are GMP-certified for the manufacturing of IMP clinical batches (Phases I-III) as well as commercialized products. Our laboratories are prepared to work with over 30 key pharmaceutical technologies, all API types from OEB classes 1-5 and narcotics, innovative technologies, hard-to-make formulations in a...
Product Thermal characterization of the product

Having information on the thermodynamic behaviour of our formula is critical to identify the critical product temperatures. At Comser, we have the following technology to characterize the product:
- Freeze Drying Microscope (FDM)
- Differential Scanning Calorimetry (DSC)

And with such,...
Product Aseptic Fill Finish

We offer two convenient fill-finish options for parenteral drug products: prefilled syringe and vials. As a leading pharmaceutical partner, we can provide all necessary elements of delivering high-quality parenteral products for clinical and commercial needs.

AbbVie will leverage its know...
Product Contract Development and Manufacturing

We are a Pharmaceutical contract development and manufacturing company authorised for the preparation of medicinal products and medical devices in liquid, suspension, gel and cream form, lyophilisates and ointments. Our services include formula development, pilot studies in the laborato...
Product Tailored Inhaled Development Services

From one-off studies and specialist techniques through to full development services, our inhalation services can support your programme through all stages of clinical development and get your product ready for commercial manufacturing.

We understand different customers may require different t...
Product Pantoprazole Pd.Inj.Sol 40mg/Vial (EU CTD Available)

Pantoprazole 40 mg/Vial Powder for Solution for Injection
Reference Product: Controloc® / Takeda
Description: Pantoprazoleis a proton pump inhibitor indicated for the treatment of the Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) and in Pathological hypersecretion ...
Product Food Supplement range of products

We offer a wide range of food supplements ready to be put on the market. Available formulations in Basic Health - Energy - Osteo and Joint Care - Immuno and Womens' Health.

We can also realize your idea of product and offer a full customised development.

Contact us for more info
Product Pulmonary Delivery

Where particle size and performance really matters, Upperton have the expertise.
Drug delivery into the lung is one of the fastest growing, yet technically challenging areas of pharmaceutical development. Producing a successful pulmonary drug product requires expertise in formulation development, part...
Product Fourier PAT

We celebrate the arrival of our synTQ by Optimal NMR adapter – opening the door to a new world of PAT for the Bruker Fourier 80. This brings a wealth of structural information and direct quantification to online chemical and bioprocess monitoring, resulting in further reductions in risk and cost.
Product Sterile suites capabilities

CLINICAL AND COMMERCIAL MANUFACTURING
A UNIQUE MANUFACTURING SYSTEM SPECIALLY DESIGNED FOR ANTICANCER DRUGS, WITH THE FLEXIBILITY TO MANAGE SMALL MOLECULES AND THE COMPLEXITY OF ADCs
Product Ampoules Filling

As the leading CDMO, Mefar offers wide range of products which including ampoule filling between 1ml to 30 ml either aseptically or terminally sterilized.
All services at Mefar are EMA certified, please contact us for additional GMP certifications we hold.

At Birgi Mefar Group, we also manufa...
Product Formulation Development

MedPharm has more than 20 years’ experience developing topical and transdermal formulations. We can begin as early as API screening and support pre-formulation activities, lead formulation selection, formulation optimization and reverse engineering. We have had a role in taking over 55 products to mark...
Product Dexolve

Dexolve is the first generic USP and EP-conform Betadex Sulfobutyl Ether Sodium for:• solubility enhancement (10 to 100,000 fold) • Improvement of chemical stability • Increased bioavailability, facilitated delivery • Reduced aggregation • Moderate irritationor reduced side-effects • Maximiz...
Product Chemical Peelings

Professional use. Chemical peels are topical treatments, mainly formulated on acids, designed to eliminate in a controlled way the most superficial layers of the skin, stimulating cell renewal and improving significantly its appearance. The most remarkable clinical effect is rejuvenation.
Product Products for pets

Products for pets : tablets, powders, oral gels and pastes ... filled in specific packaging according to species, product, dosage, use : syringe, airless pump bottle, plastic tube, plastic bottle // Using animal orgin factors to enhance palability // Compliant to EU regulation
Product GummiBiotics Defense Gummy

Supercharge immune health and gain more time for a vibrant, productivelife with our innovative postbiotic gummy, powered by EpiCor®.
EpiCor® postbiotic, an innovative ingredient from Cargill, is clinically provento support immune and gut health
.• Supported by 15 published studies, clinically shown...
Product CordenPharma Sterile Powder Lyophilized Vials

CordenPharma has extensive experience in sterile contract manufacturing with a wealth of lyophilization expertise. In particular, the optimization of the freeze drying process as it relates to cycle times represents a critical attribute for complex parenteral product development. CordenPharma experts suppo...
Product Cisplatin

CISPLATIN 50 mg lyophilized vials – Several types of cancer (testicular, ovarian…). Authorized EU-CTD Dossier
Product tiny-TIMsg

The tiny-TIMsg system, as part of the SurroGUT™ platform, precisely mimics the upper GI tract and all physiologically relevant processes; including the pressure, shear forces and phase specific gastric emptying. The tiny-TIMsg consists of an advanced gastric compartment (TIMagc) and small intestine co...
Product Complex injectables

25+ years of experience in complex formulation development, including ready to-use specialty products and novel drug delivery systems

Proven expertise in niche and complex dosage formats (single and dual-chamber bag, Lyo-vials, PFS, cartridges) to address hospital needs and improve patient experienc...
Product Vitarojal® classic 1000 mg liquid food supplement with royal jelly and h...

Apipharma d.o.o. Offers a wide range of products which includes vitaroja.l 1 vial contains 333.3 mg of lyophilized royaljelly which is the equivalent to 1000 mg offresh royal jelly.Vitarojal® classic 1000 mg contain royaljelly which is known for its biostimulating properties.Each vial contains 1000 mg of r...
Product Formulation Development

Formulation & process development of complex oral solids drug products. Specialized in solubility enhancement, drug delivery, controlled release, functional coating, granulation, pellets & micropellets. From technical feasibility to GMP for clinical trials and commercial manufacturing.Core compente...
Product Nanosol

NanoSol is a technology for the production of nano-sized drug particles. Formulation of a drug substance in nano-particle form significantly increases the surface area available for dissolution. A ten-to-twenty-fold increase in surface area can result from reducing particle size from a micronized dru...
Product Aseptic filling and visual inspection

For over 40 years, our fill and finish services have helped to keep the world supplied with injectable therapies, many of which are lifesaving. Our partnerships with customers start in the first steps of clinical manufacturing through commercial-scale filling and beyond, including management throughout the...
Product RheaLyo Mono Freeze-Dryer

The Single Vial Continuous Freeze-Drying System is specifically designed for R&D production based upon the RheaVita Continuous Freeze-Drying Technology. The equipment is perfectly suited for very fast formulation and process development and optimization using a very limited amounts of product by mimick...
Product Pre-Formulation / Formulation

Asymchem understands that early phase work focuses on learning as much as possible about a drug compound. Our experience across numerous chemical classes and multiple dosage forms, and our ability to develop analytical methods to assess chemical identity, purity, compatibility, and stability, makes us a na...
Product NABIQASIM INDUSTRIES / Lyophilization of PPIs / Lyophilized Infusion / I...

Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes; f...
Product Succinyl Gelatin Injection

Succinyl Gelatin Injection is a plasma volume substitute. This means, it replaces fluid lost from the circulation. It is used to replace blood and body fluid, which have been lost as a result of, for example, an operation, an accident or a burn. It can be used instead of, or as well as, a blood transfusion...
Product ENNA MOISTURIZING GEL VAGINAL DRYNESS

ENNA MOISTURIZING GEL AGAINST VAGINAL DRYNESS. MEDICAL DEVICE. VEGAN. CLINICALLY AND GYNECOLOGICALLY TESTED
Product E.SOLVE | SOLVING BIOAVAILABILITY CHALLENGES

E.SOLVE accelerates your journey to the clinic supporting as early as possible your formulation strategy from discovery to market approval.
· When you deal with a challenging API, partner with Evotec’s screening experts to guide your process through every challenge along the drug discovery and devel...
Product SERVICES

With a wide range of new customer services, you will find in RENOLIT Healthcare a strong partner with innovative and customised full-service solutions to meet your specific challenges.

Whether as part of a joint venture or in the form of a partnership - as a service partner RENOLIT Healthcare provid...
Product Somatropin for injection USP 10 IU - Shreetropin

A human growth hormone drug for dwarf child

Shree Venkatesh International Ltd offers a wide range of pharmaceutical products, including the Somatropin for injection USP 10 IU-Somatropin.
• Use: Treatment for children with growth failure due to inadequate secretion of...
Product Clobetasol Propionate

CTD-DMF, CEP & USDMF
Product Nitrosamine Mitigation

Very few CDMOs can claim Adare's level of experience in mitigating the presence of nitrosamine. We can employ our own-in-house mitigation processes to develop the best long-term control strategies for your product.

Regain control of your product with NitroCLEARx • Receive real-world mitiga...
Product Formulation Development including Inhaled Products

Inhaled products and formulation development: The development of drugs using experimental design approaches with integrated stability testing and storage is available from us. Our formulation specialists can provide a wide range of formulations in a timely and cost-effective manner in order to identify t...
Product Geoclock® Technology_Customisable chronotherapy

Geoclock® allows for timed release of drugs that is independent of food or pH. Geoclock® is a validated oral drug delivery technology that can be used to release the drug from the tablet after a pre-determined lag-time that is independent of food or pH. Geoclock® can additionally be used for multi...
Product Parenteral manufacturing

Dedicated to manufacturing parenteral dosage forms, Alcami’s Charleston, South Carolina site supports preclinical production through commercial launch and supply. This US- and EU-compliant and DEA-licensed sterile manufacturing facility is fully integrated with our Wilmington, North Carolina packaging and ...
Product ADAPTEK® TECHNOLOGY

ADAPTEK® TECHNOLOGY is the general name for our 4 international patents and expertise in nanotechnology and controlled release systems.This is a transversal technology that allows to develop customized biopolymeric nanohydrogels, allowing the load with different API (drugs, vitamins, growth factors, etc.)....
Product LIPEX® Liposome Extruders

Evonik’s platform of LIPEX® liposome extruders have set the industry standard for liposomal drug product manufacturing for almost 30 years. LIPEX® liposome extruders are widely used across the pharmaceutical and biotechnology industry to create homogeneous populations without the need f...
Product TOPS - Topical Patch Systems

Topical Patch Systems (TOPS) from LTS is a flexible, ready to use platform designed to deliver a range of topical therapies, while avoiding first-pass metabolism and improving drug efficacy. With teams of experts on hand across the globe, we are here to support your next innovative drug delivery developmen...
Product Formulation Development

Our Formulation Scientists and Process Engineers are experts in poorly soluble compounds and high containment operations. Our formulation development lab and pilot plant suites are specifically designed for high containment and outfitted with cGMP matching technologies. We follow a data driven approach to ...
Product Development Service

Lomapharm GmbH provides wide range of services which includes development service. It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev...
Product Continuous Manufacturing of Formulations in Minutes Instead of Hours

Microinnova Engineering GmbH has successfully commissioned two continuous formulation production plants for a European client. The design of the fully automated plant is very compact, which makes it possible to easily transport & install it at a different manufacturing site on the other side of the wor...
Product Formulation and process development

Do you have an NCE that needs to be formulated in a solid dosage form or having challenging process and formulation questions, then XEDEV is your partner to assist you, as we are specialised in formulation and process development through drying, granulation, tableting and/or coating processes.

P...